Navigating the Regulatory Requirements for Pharmaceutical Export
The global export of pharmaceutical products comes with its own challenges and tedious pathways.
The challenges are due to non-unified pathways.
Each country has diversified standards.
The hurdles incurred in –
- Managing data integrity
- Complex clinical trial approvals
- Tracing regulatory updates
- Language difficulties.
Aprazer Healthcare‘s Regulatory Assurance and Compliance
Our regulatory expertise is highly flexible and adapts to the changing regulatory landscape.
We smoothly navigate the country –specific norms.
We are the largest pharmaceutical exporters to countries in Southeast Asia, Africa, and South America.
Our quality manufacturing process adheres to WHO-GMP and EU- GMP standards.
We are ahead of the regulatory challenges through our effective and transparent conduct.
- Proper documentation
- Compliance with local labeling and packaging
- Dossier submissions
- securing regulatory approvals and licenses
The steps of the regulatory procedure-
The market research –
The targeted country is to be researched for its specifications.
- Understanding specific dug classifications.
- Evaluating current practices and pitfalls.
- Connecting the regulatory authorities
- understanding legal and ethical obligations
- Understanding disease prevalence and demand
- Evaluating logistic feasibilities
GMP compliance for export –
Adherence to GMP ensures that the products that are to be exported are of standard quality and safe.
It ensures that they are manufactured under controlled environment.
The standard certification consists of WHO-GMP adherence.
Other certifications include the country –specific GMP practices.
It includes – USFDA, EU-GMP.
It also includes the standard distribution practices for international transport.
Good distribution practices are required, especially for cold chain integrity.
Registration of the product/licensing
It is a process in which the specific country approves and provides a license to sell the drug in its country.
It includes submission of detailed documentation-
- License for manufacturing
- Export license
- GMP certificate
- free sale certificate
- Dossier (CTD format)
Labeling and packaging requirements-
It ensures proper labels and packaging of the product.
It is acceptable in the specific country.
The label is displayed in the local language.
The barcodes and trademarks are added.
It ensures product originality.
Protecting Intellectual Property Rights –
It is important to secure a company’s inventions through patents.
IPR secures the trademarks and copyrights of the company in the targeted country.
It reduces the duplication or misuse of the products.
Post marketing surveillance
The pharmacovigilance process monitors adverse drug effects to establish product safety.
Post-market surveillance is the process of continuously monitoring the safety and compliance of the drug after being launched into the market or a specific country.
Quality assurance –
It is the process by which the quality of the product is assured, including safety and therapeutic efficacy.
It includes an overall assessment of the manufacturing and distribution to ensure the exported product is reliable.
Custom and trade compliance-
It includes all the custom formalities to streamline the shipping process.
It consists of –
- Export/import codes
- Shipping bills
- Export bills
- Trade agreements
- Tariffs
When navigating the regulatory process, Aprazer Healthcare is the choice as a pharmaceutical manufacturer, exporting the highest quality pharmaceutical products.
